Class II — CPM Medical Consultants, LLC.
| Recalling firm | CPM Medical |
|---|---|
| Registered facility | CPM Medical Consultants, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States. |
| Product | Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, OS200518, OS200520, OS200522, OS200616, OS200618, OS200620, OS200622, OS421300, OS421302, OS421304, OS421306, OS421308, OS421208, OS421210, OS421212, OS421000L, OS421000R, OS421002L, OS421002R, OS421004L, OS421004R, OS421006L, OS421006R, OS42260LL, OS42260LR, OS42260ML, OS42260MR, OS42260SL, OS42260SR, OS42260XSL, OS422… |
| Quantity | 3317 |
| Distribution | US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL. |
| Initiated | 2025-09-17 |
| Classified | 2025-10-21 |
| Recall number | Z-0230-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CPM Medical Consultants, LLC. (Z-0230-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97679/
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